Aerie Pharmaceuticals announced the European Commission (EC) has granted a marketing authorization for Rhokiinsa (netarsudil ophthalmic solution) 0.02% for the reduction of elevated IOP in adult patients with primary open-angle glaucoma or ocular hypertension.
The marketing authorization application (MAA) for Rhokiinsa was accepted for review by the European Medicines Agency (EMA) in October 2018. Aerie received a positive scientific opinion recommending approval of the Rhokiinsa MAA from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in September 2019.
“The receipt of an EC marketing authoriation for Rhokiinsa is an important milestone for Aerie as it once again demonstrates the potential value of Aerie’s netarsudil franchise at an international level,” Vicente Anido, Jr., Phd, Chairman and Chief Executive Officer at Aerie, said in a company news release. “Importantly, this approval also sets the stage for our filing of an MAA for Roclanda with the EMA by early 2020 and we would expect that review process would take approximately one year. In the interim, we look forward to our Rocklatan, known as Roclanda in Europe, Mercury 3 data expected by mid-2020. These data will help set the stage for our commercialization strategy in Europe.”
Rhokiinsa was approved by the FDA in December 2017 under the trade name Rhopressa for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. Roclanda was approved by the FDA in March 2017 under the trade name Rocklatan for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.
The marketing authorization is valid in all 28 countries of the European Union, plus Iceland, Norway and Liechtenstein.